APACHE-2: Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention

Sponsor

University Hospital, Tours (Other)

Overall Status

Completed

CT.gov ID

NCT01588301

Collaborator

(none)

5,998

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Scientific Context:

High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.

The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home.

Description of the project :

Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:

Intervention arm 1:

Women will receive a further invitation to make a cervical smear

Intervention arm 2:

Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV).

For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.

Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Human Papillomavirus Infection	Behavioral: Attending for cervical cytology Behavioral: Kit for Self-collected vaginal sample	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

5998 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 : Further invitation by mail Further invitation to attend for cervical cytology	Behavioral: Attending for cervical cytology A further invitation to attend for cervical cytology are going to be sent by mail to women
Experimental: Group 2 : Kit for Self-collected vaginal sample Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV)	Behavioral: Kit for Self-collected vaginal sample Kit for self-collected vaginal sample are going to be directly sent at women's home
No Intervention: Group 3: Control

Arm

Intervention/Treatment

Experimental: Group 1 : Further invitation by mail

Further invitation to attend for cervical cytology

Behavioral: Attending for cervical cytology

A further invitation to attend for cervical cytology are going to be sent by mail to women

Experimental: Group 2 : Kit for Self-collected vaginal sample

Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV)

Behavioral: Kit for Self-collected vaginal sample

Kit for self-collected vaginal sample are going to be directly sent at women's home

No Intervention: Group 3: Control

Outcome Measures

Primary Outcome Measures

Comparison of women's attitude according to the arm: participation or not to a whole screening action [9 months after the beginning of the study (sending of mails)]
Comparison of attitudes among women not attending organized cervical cancer according to the type of intervention or the lack of intervention: participation or not to a whole screening action. Are considered as whole screening action: cervical smear HPV DNA testing on self-collected vaginal sample negative (no infection by a high-risk HPV) HPV DNA testing on self-collected vaginal sample positive (infection by a high-risk HPV) followed by a cervical smear

Secondary Outcome Measures

Analysis in sub-groups [9 months after the beginning of the study (sending of mails)]
Analysis in sub-groups in order to compare the efficacy of interventions according to : The age Health insurance system Distribution map (urban area, peri-urban area, rural area)
Identification of the psychological determinants and mechanisms (checks and motivational factors) [9 months after the beginning of the study (sending of mails)]
Identify the psychological determinants and mechanisms (checks and motivational factors) that can affect enrollment to the screening procedure for self-collection vaginal sample or cervical smear. Nine months after the beginning of the study, a questionnaire will be send to the 6000 women.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria :

Women from 30 to 65 years
Living in Indre-et-Loire (french territorial division 37)

Exclusion Criteria :

Women who attend organized cervical cancer screening or who answer to the invitation
Cervical smear made in the three last years
HPV linked cervical condition undergoing treatment
Hysterectomy (including cervix)